In the pharmaceutical industry, pharmaceutical products including diagnostic products comprise a container (e.g., a bottle, a blister pack or other packaging) containing a plurality of "unit dosage forms" or "unit diagnostic forms." Each of such unit forms contains a pharmaceutically- or biologically-active ingredient or ingredients and inert or inactive ingredient(s).
The pharmaceutically-active ingredient typically forms a drug. The diagnostic form may comprise a reagent or the like for use in diagnostic tests, and may be part of a set which includes several different reagents or active ingredients. Moreover, the diagnostic form may comprise an antibody, an antigen, or labeled forms thereof and the like.
A pharmaceutically- or biologically-active ingredient for use in a unit form may be supplied as a powder comprising a plurality of active-ingredient particles. Such active-ingredient particles are combined with inert or inactive ingredient particles to form a plurality of "major particles." The major particles are quite small, with dimensions on the order of microns. Such major particles are typically combined with one another to create the final unit dosage or diagnostic form (e.g., tablet, caplet, test strip, capsule, etc.).
There may be significant variation in the amount of pharmaceutically- or biologically-active ingredient in one major particle and the next. Since a large number of major particles are required to create a final unit form, the aforedescribed particle-to-particle variation may result in a substantial variation in the amount of active ingredient between one unit form and the next. Thus, any given final form may contain substantially more or less than a desired amount of active ingredients.
Destructive analytical screening procedures are conventionally performed to assess the amount of active ingredient(s) in final unit forms. Since such procedures destroy the unit forms, a statistical sampling is performed whereby a relatively small number of forms per batch are actually sampled and tested. Such screening procedures disadvantageously provide no assurance that all forms in a given batch contain a desired amount of the pharmaceutically- or biologically-active ingredients. In fact, such statistical methods practically "guarantee" that a statistically determinable percentage of the forms in each batch will be out of specification.
As such, the art would benefit from a method and apparatus that provides improved control over the active-ingredient content of unit dosage and diagnostic forms.